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Hemodialysis is a cause of carnitine deficiency. The deficiency of carnitine induces an anemia by an increase fragility of the red blood cells, a muscular fatigue and a cardiac dysfunction. We proposed to evaluate the benefit of an early administration of L-carnitine in hemodialysis patients. The patients should be included in the first month after the start of chronic hemodialysis, randomized to receive L-carnitine or placebo and should be followed-up during one year.
The first aim of the study is to compare the resistance index to erythropoietin (hemoglobin level / rHuerythropoietin dose) with L-carnitine versus placebo Double blind randomized study evaluating the supplementation with L-carnitine versus placebo in patients beginning chronic hemodialysis for less than 1 month.
Primary outcome to compare rHuerythropoietin resistance index defined as hemoglobin level / rHuEPO dose ratio with L-carnitine and with placebo.
Secondary endpoints to compare acylcarnitine / carnitine ratio, number of red blood cells transfusion, physical status, quality of life, hypotensive episodes, lipid profile, diabetes profile, albuminemia, c reactive protein.
Several variables that influenced primary and secondary endpoints will be included in a multivariate analysis; albuminemia, c reactive protein, iron status, dialysis efficiency, protein intake, lipid intake, treatment with additional vitamins (C, B9, B6), treatment with statins, treatment of predialysis hypotension by midodrine, antihypertensive treatments.
Statistical analysis:
Following analysis in both intention to treat and per protocol analysis:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | L-Carnitine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| L-Carnitine | Drug | L-Carnitine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Resistance index to erythropoietin | Resistance index to erythropoietin | during de study |
| Haemoglobin level/weekly rHuerythropoietin dose in patients receiving l-carnitine versus those receiving the placebo. | Haemoglobin level/weekly rHuerythropoietin dose in patients receiving l-carnitine versus those receiving the placebo. | during the study |
| Measure | Description | Time Frame |
|---|---|---|
| Acylcarnitine/carnitine ratio measured quarterly | Acylcarnitine/carnitine ratio measured quarterly | during the study |
| Number of red blood cells transfusion per patient during the study, data collected monthly |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lucile Mercadal, MD,PhD | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assistance Publique Hopitaux de Paris | Paris | 75004 | France | |||
| HOPITAL LA PITIE SALPETRIERE, service de Néphrologie |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39498822 | Derived | Marshall MR, Wang MY, Vandal AC, Dunlop JL. Low dialysate sodium levels for chronic haemodialysis. Cochrane Database Syst Rev. 2024 Nov 5;11(11):CD011204. doi: 10.1002/14651858.CD011204.pub3. | |
| 36472884 | Derived | Nishioka N, Luo Y, Taniguchi T, Ohnishi T, Kimachi M, Ng RC, Watanabe N. Carnitine supplements for people with chronic kidney disease requiring dialysis. Cochrane Database Syst Rev. 2022 Dec 6;12(12):CD013601. doi: 10.1002/14651858.CD013601.pub2. |
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| ID | Term |
|---|---|
| D000740 | Anemia |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D002331 | Carnitine |
| ID | Term |
|---|---|
| D050337 | Trimethyl Ammonium Compounds |
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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Number of red blood cells transfusion per patient during the study, data collected monthly
| during the study |
| Predialysis hypotension per patient during the study, data collected monthly | Predialysis hypotension per patient during the study, data collected monthly | during the study |
| SF 36 physical and total score at inclusion and at the end of the study | SF 36 physical and total score at inclusion and at the end of the study | during the study |
| Lipid profile, measured quarterly | Lipid profile, measured quarterly | during the study |
| HbA1c, measured quarterly for diabetic patients and patients with glucose intolerance | HbA1c, measured quarterly for diabetic patients and patients with glucose intolerance | during the study |
| Albuminemia measured quarterly | Albuminemia measured quarterly | during the study |
| c reactive protein measured quarterly | c reactive protein measured quarterly | during the study |
| Paris |
| 75013 |
| France |
| 30408788 | Derived | Mercadal L, Tezenas du Montcel S, Chonchol MB, Debure A, Depreneuf H, Servais A, Bassilios N, Assogba U, Allouache M, Prie D. Effects of L-Carnitine on Mineral Metabolism in the Multicentre, Randomized, Double Blind, Placebo-Controlled CARNIDIAL Trial. Am J Nephrol. 2018;48(5):349-356. doi: 10.1159/000494338. Epub 2018 Nov 8. |